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Mesh, Surgical, Collagen, Fistula

Page Type
Product Code
Definition
For reinforcement of soft tissue where weakness exists during the repair of fistulas.
Physical State
A collagen mesh; square, rectangular, round or of other various shapes
Technical Method
A collagen mesh for the reinforcement of soft tissue
Target Area
Anorectal, enterocutaneous, and recto-vaginal fistulas
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.3300
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.3300 Surgical mesh

§ 878.3300 Surgical mesh.

(a) Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

(b) Classification. Class II.

Mesh, Surgical, Collagen, Fistula

Page Type
Product Code
Definition
For reinforcement of soft tissue where weakness exists during the repair of fistulas.
Physical State
A collagen mesh; square, rectangular, round or of other various shapes
Technical Method
A collagen mesh for the reinforcement of soft tissue
Target Area
Anorectal, enterocutaneous, and recto-vaginal fistulas
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.3300
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.3300 Surgical mesh

§ 878.3300 Surgical mesh.

(a) Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

(b) Classification. Class II.